How to Get Increlex (mecasermin) Covered by Humana in California: Forms, Appeals Timeline & PA Requirements
Answer Box: Getting Increlex Covered by Humana in California
Eligibility: Children ≥2 years with severe primary IGF-1 deficiency (height ≤-3.0 SD, low IGF-1, normal/elevated GH) prescribed by pediatric endocrinologist.
Fastest Path: Submit prior authorization with comprehensive lab results, growth charts, and medical necessity letter through Humana's provider portal. Standard review takes 72 hours; expedited available for urgent cases.
First Step Today: Contact your pediatric endocrinologist to gather IGF-1 levels, growth hormone tests, and serial height measurements spanning adequate time periods. If already denied, you have 65 days to appeal.
Table of Contents
- Plan Types & Coverage Implications
- Formulary Status & Tier Placement
- Prior Authorization Requirements
- Specialty Pharmacy Network
- Cost-Share Dynamics
- Submission Process & Forms
- Appeals Playbook for California
- Common Denial Reasons & Solutions
- When to Escalate to State Review
- FAQ
Plan Types & Coverage Implications
Humana operates primarily Medicare Advantage and Part D plans in California, with some commercial coverage. Your plan type affects how Increlex coverage works:
Medicare Advantage (Part C)
- Includes prescription drug coverage
- PA decisions typically within 72 hours standard, 24 hours expedited
- Appeals follow Medicare timeline: 65 days from denial notice
Medicare Part D
- Standalone prescription drug plans
- Increlex is covered on Humana's specialty formulary but requires prior authorization
- Same appeal timelines as Medicare Advantage
Commercial Plans (HMO/PPO)
- Less common in California for Humana
- May have different PA criteria and appeal processes
- Subject to California's robust Independent Medical Review (IMR) system
Note: Humana's PA denial rate is approximately 3.5% among major Medicare plans—relatively low, but denials often center on documentation gaps rather than medical necessity.
Formulary Status & Tier Placement
Increlex 10 mg/ml subcutaneous solution is listed on Humana's specialty medication formulary as a covered drug requiring prior authorization. The medication is classified as:
- Specialty tier: Higher cost-sharing than standard medications
- Prior authorization required: Must meet specific clinical criteria
- Quantity limits: May apply based on FDA dosing guidelines
- Specialty pharmacy only: Dispensed through CenterWell Specialty Pharmacy
Alternative Agents on Formulary If Increlex is denied, Humana may suggest:
- Growth hormone therapy (if patient has GH deficiency rather than primary IGF-1 deficiency)
- Nutritional interventions (inappropriate for true severe primary IGF-1 deficiency)
Prior Authorization Requirements
For initial approval, patients must meet all of the following criteria based on standard PA policies for severe primary IGF-1 deficiency:
Coverage at a Glance
| Requirement | What it means | Where to find it | Source |
|---|---|---|---|
| Age ≥2 years | Patient must be at least 2 years old | Birth certificate/medical records | FDA labeling |
| Height ≤-3.0 SD | Severe short stature (below 99.9th percentile) | Growth charts, measurements | Pediatric endocrinologist |
| Low IGF-1 levels | Below normal reference range for age/gender | Laboratory results | Endocrine lab report |
| Normal/elevated GH | Growth hormone stimulation test | GH stimulation test results | Endocrine testing |
| Specialist prescription | Pediatric endocrinologist required | Provider credentials | Medical license verification |
| Open epiphyses | Growth plates still open | X-ray or bone age study | Radiology report |
Required Documentation Checklist
Essential Laboratory Results
- IGF-1 levels with age/gender-specific reference ranges
- Growth hormone stimulation test showing normal or elevated GH
- IGFBP-3 levels (supporting evidence)
- Exclusion of secondary causes (thyroid function, renal function)
Growth Documentation
- Serial height measurements over ≥6 months
- Growth velocity calculations
- Height standard deviation scores
- Growth charts with clear plotting
Clinical Records
- Specialist consultation notes with clear diagnosis
- ICD-10 codes for severe primary IGF-1 deficiency
- Previous treatment history (if any)
- Treatment goals and monitoring plan
Specialty Pharmacy Network
Humana uses CenterWell Specialty Pharmacy for Increlex dispensing and patient support services.
Enrollment Process
- Your doctor submits the PA request to Humana
- Once approved, prescription is sent to CenterWell
- CenterWell contacts you to set up delivery and counseling
- Medication ships via overnight delivery with temperature monitoring
Support Services Include
- Clinical counseling on injection technique
- Side effect management (hypoglycemia monitoring)
- Adherence support and refill reminders
- Financial assistance program navigation
Contact Information
- CenterWell Specialty: Available through Humana's specialty pharmacy portal
- Patient support: Contact number provided after enrollment
Cost-Share Dynamics
Medicare Part D Cost Structure
- Specialty tier: Typically 25-33% coinsurance
- Deductible: May apply before coverage begins
- Coverage gap: "Donut hole" may affect out-of-pocket costs
- Catastrophic coverage: After reaching out-of-pocket maximum
Cost-Saving Options
- Manufacturer patient assistance: Check eligibility requirements
- State pharmaceutical assistance programs
- Medicare Extra Help (Low-Income Subsidy)
Important: This is educational information only. Actual costs vary by plan and individual circumstances.
Submission Process & Forms
Step-by-Step: Fastest Path to Approval
- Gather Documentation (Patient/Family)
- Collect all growth charts and lab results
- Timeline: 1-2 days
- Schedule Specialist Consultation (Patient)
- Ensure pediatric endocrinologist evaluates case
- Timeline: 1-4 weeks depending on availability
- Submit Prior Authorization (Provider)
- Use Humana's provider portal or fax
- Include all required documentation
- Timeline: Same day submission
- Humana Review (Plan)
- Standard review: 72 hours
- Expedited review: 24 hours (if urgent)
- Approval Notification (Plan to Provider/Patient)
- Approval letter sent to prescriber and patient
- Timeline: Within review period
- Specialty Pharmacy Setup (CenterWell)
- Patient enrollment and medication shipment
- Timeline: 2-3 business days after approval
- Treatment Initiation (Patient)
- Begin therapy with specialist monitoring
- Timeline: Upon medication receipt
Appeals Playbook for California
If your initial PA request is denied, California residents have strong appeal rights through both Humana and state regulators.
Internal Appeals (Humana)
Timeline: 65 days from denial notice to file appeal Standard Response: 7 days for benefits appeals, 14 days for payment appeals Expedited Response: 72 hours when medically urgent
Required Information
- Patient name, address, and Medicare number
- Specific drug being appealed (Increlex/mecasermin)
- Reason for appeal with supporting documentation
- Prescriber's medical necessity statement
External Review (California IMR)
If Humana upholds the denial, California's Independent Medical Review system provides external appeal rights.
Success Rate: Approximately 73% of IMR cases result in overturned denials Timeline: 30 days standard, 3 days expedited for urgent cases Cost: No fee to patients
How to Request IMR
- File internal appeal with Humana first
- If denied or no response in 30 days, contact DMHC Help Center at 888-466-2219
- Submit IMR application within 6 months of appeal decision
- Independent physician experts review your case
- DMHC decision is binding on Humana
Common Denial Reasons & Solutions
| Denial Reason | Required Documentation | How to Overturn |
|---|---|---|
| "Not primary IGF-1 deficiency" | Comprehensive endocrine testing | Provide GH stimulation test showing normal/elevated GH with persistently low IGF-1 across multiple time points |
| "Insufficient growth documentation" | Serial height measurements | Submit growth charts spanning ≥6 months with calculated growth velocity and standard deviation scores |
| "Non-formulary medication" | Medical necessity justification | Request formulary exception demonstrating why standard growth hormone therapy is inappropriate for primary IGF-1 deficiency |
| "Missing specialist evaluation" | Pediatric endocrinology consultation | Ensure prescription comes from board-certified pediatric endocrinologist with detailed assessment |
Clinician Corner: Medical Necessity Letter Essentials
Your pediatric endocrinologist's letter should include:
Clinical Presentation
- Clear diagnosis with ICD-10 codes
- Height measurements with standard deviation calculations
- Growth velocity documentation over time
Laboratory Evidence
- IGF-1 levels below 5th percentile for age/gender
- Normal or elevated growth hormone on stimulation testing
- Exclusion of secondary causes (malnutrition, hypothyroidism)
Treatment Rationale
- Why growth hormone therapy is inappropriate
- Expected benefits of mecasermin therapy
- Monitoring plan for hypoglycemia and other side effects
Guideline References
- FDA prescribing information
- Pediatric Endocrine Society guidelines
- Relevant peer-reviewed literature
When to Escalate to State Review
Consider escalating to California's Department of Managed Health Care if:
- Humana fails to respond within required timeframes
- You believe the denial contradicts medical evidence
- The plan is not following its own coverage policies
- You need urgent medication access
Contact Information
- DMHC Help Center: 888-466-2219
- Online complaint filing: healthhelp.ca.gov
- No cost to file complaints or IMR requests
From our advocates: We've seen families successfully overturn Increlex denials by providing IGF-1 results from three different time points clearly showing values below the 5th percentile, combined with comprehensive growth charts spanning at least one year. The key is eliminating any doubt about the diagnosis through thorough documentation.
FAQ
How long does Humana prior authorization take for Increlex in California? Standard review is 72 hours; expedited review for urgent cases is 24 hours. Appeals must be filed within 65 days of denial.
What if Increlex is not on my Humana formulary? Increlex is on Humana's specialty formulary but requires PA. If denied, you can request a formulary exception with medical necessity documentation.
Can I request an expedited appeal for Increlex? Yes, if your doctor certifies that waiting for standard review could seriously harm your child's health. Expedited appeals receive decisions within 72 hours.
Does step therapy apply to Increlex? Typically no, since Increlex treats primary IGF-1 deficiency while growth hormone treats GH deficiency. However, plans may require documentation that GH therapy is inappropriate.
How much does Increlex cost with Humana coverage? Costs vary by plan. Specialty tier medications typically require 25-33% coinsurance. Contact Humana member services for specific cost-sharing information.
What happens if the California IMR overturns Humana's denial? Humana must authorize the medication within 5 business days of the IMR decision. The plan cannot appeal the IMR ruling.
About Counterforce Health
Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform identifies denial reasons and drafts point-by-point rebuttals aligned to each plan's specific policies, pulling the right clinical evidence and citations to support medical necessity. For complex cases like Increlex appeals, having organized documentation and payer-specific strategies can significantly improve approval odds. Learn more at www.counterforcehealth.org.
Sources & Further Reading
- Humana Medicare Drug List
- Humana Provider Portal - Pharmacy Exceptions & Appeals
- California DMHC - File a Complaint or IMR
- CenterWell Specialty Pharmacy
- Increlex Prescribing Information
- Medicare Part D Appeals Process
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider about treatment options and contact your insurance plan directly for coverage verification. For assistance with appeals or coverage questions in California, contact the DMHC Help Center at 888-466-2219.
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